NDC | 62032-105-36, 62032-121-90, 62032-122-10, 62032-523-04 |
Set ID | 36b030cc-024d-43f1-89b4-8d121f62aeff |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | OMP, INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- C-Cleansing Gel 6 fl. oz. (177 mL.) AM+PM
- Directions
- Warnings
-
Ingredients
water (aqua), sodium laureth sulfate, sodium lauroyl oat amino acids, cocamidopropyl betaine, aloe barbadensis leaf juice (aloe barbadensis), ascorbic acid, glycerin, medicago sativa (alfalfa) extract, borago officinalis extract, chamomilla recutita (matricaria) flower extract (chamomilla recutita extract), sodium chloride, saponins, xanthan gum, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), red 33 (CI 17200), yellow 5 (CI 19140)
- C-Balancing Toner 6.7 fl. oz. (198 mL.) AM+PM
- Directions
- Warnings
- Ingredients
- C-Clarifying Serum Normal to Oily (Skin Lightening Serum) NDC 62032-122-10 1 fl. oz. (30 mL.) Hydroquinone USP, 4% Rx Only AM
- Indications and usage
-
Dosage and administration
Use once daily in the morning. Apply 5-7 drops to the entire face, or as directed by your skin care physician. Massage in gently. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
- Warnings
- DESCRIPTION
- SPL UNCLASSIFIED SECTION
- C-Therapy Night Cream (Skin Lightener) NDC 62032-105-36 Net wt. 2 oz. (57 g.) Hydroquinone USP, 4% Rx Only PM
- Indications and usage
-
Dosage and Administration
Use daily in the evening. Dispense a small amount (approximately 1-2 pea-sized drops) and apply to the entire face. Massage in gently. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
-
Warnings
Avoid contact with eyes, nose, mouth, or lips. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
- DESCRIPTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Sun Shield Broad Spectrum SPF 50 Matte Net wt. 3 oz. (85 g)
- ACTIVE INGREDIENT
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: Ask a doctor
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.–2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
-
Inactive ingredients
1,2 hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
-
INGREDIENTS AND APPEARANCE
OBAGI-C RX SYSTEM NORMAL-OILY SKIN INTERVENTION
hydroquinone, octinoxate and zinc oxide kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-523 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-523-04 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, GLASS 30 mL Part 2 1 BOTTLE, PLASTIC 57 g Part 3 1 TUBE 85 g Part 4 1 BOTTLE, PLASTIC 177 mL Part 5 1 BOTTLE, PLASTIC 198 mL Part 1 of 5 OBAGI C RX SYSTEM C CLARIFYING SERUM
hydroquinone liquidProduct Information Item Code (Source) NDC:62032-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALCOHOL (UNII: 3K9958V90M) DIPROPYLENE GLYCOL (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-122-10 1 in 1 CARTON 1 30 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/2010 Part 2 of 5 OBAGI-C RX SYSTEM C-THERAPY SKIN LIGHTENING WITH VITAMINS C AND E
hydroquinone creamProduct Information Item Code (Source) NDC:62032-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) TROLAMINE SALICYLATE (UNII: H8O4040BHD) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-105-36 57 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/2004 Part 3 of 5 OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN
octinoxate and zinc oxide lotionProduct Information Item Code (Source) NDC:62032-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 105 mg in 1 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PENTYLENE GLYCOL (UNII: 50C1307PZG) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-40 STEARATE (UNII: ECU18C66Q7) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TROPOLONE (UNII: 7L6DL16P1T) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) UBIDECARENONE (UNII: EJ27X76M46) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-121-90 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/12/2013 Part 4 of 5 OBAGI-C RX SYSTEM C-CLEANSING WITH VITAMIN C
cleansing (cold creams, cleansing lotions, liquids, and pads) gelProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR ASCORBIC ACID (UNII: PQ6CK8PD0R) INGR SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR ALFALFA (UNII: DJO934BRBD) INGR CHAMOMILE (UNII: FGL3685T2X) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR D&C RED NO. 33 (UNII: 9DBA0SBB0L) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 177 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2004 Part 5 of 5 OBAGI-C RX SYSTEM C-BALANCING TONER FOR NORMAL TO OILY SKIN
cleansing (cold creams, cleansing lotions, liquids, and pads) liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) INGR BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR POLYQUATERNIUM-10 (400 MPA.S At 2%) (UNII: HB1401PQFS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 198 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 04/02/2013 Labeler - OMP, INC. (790553353) Establishment Name Address ID/FEI Business Operations PURETEK CORPORATION 785961046 MANUFACTURE(62032-523) , LABEL(62032-523) , PACK(62032-523) Establishment Name Address ID/FEI Business Operations Ei INC. 105803274 MANUFACTURE(62032-523) , LABEL(62032-523) , PACK(62032-523) , ANALYSIS(62032-523) Establishment Name Address ID/FEI Business Operations MILBAR LABORATORIES 195556790 MANUFACTURE(62032-523) Establishment Name Address ID/FEI Business Operations Bay Cities Container Corporation 066229618 RELABEL(62032-523) , REPACK(62032-523) Establishment Name Address ID/FEI Business Operations Swiss-American Products 611921669 MANUFACTURE(62032-523)